Pub Date : 2025-11-01DOI: 10.1177/23265094251396048
John M Drake, Justin Bahl, Michael A Cacciatore, Amin Ghadami, Ellie Graeden, Barbara A Han, Glen Nowak, Éric Marty, Hailey Robertson, Pejman Rohani, Sukanta Sarkar, Guppy L Stott, Amy K Winter, Bogdan I Epureanu
The COVID-19 pandemic exposed significant gaps in the coordination and integration of efforts required to effectively manage large-scale infectious disease outbreaks. A successful response to such crises demands the swift and ongoing synthesis of information and activities across multiple sectors, including government, healthcare, and private industry. However, these systems are often managed in isolation, leading to misaligned policies, fragmented communications, and inefficiencies that hinder pandemic response efforts. To address these challenges, we propose adopting a systems-of-systems (SOS) paradigm to enhance epidemic intelligence and improve preparedness and response during infectious disease emergencies. The SOS approach, widely used in engineering, offers a framework for integrating diverse fields such as virology, ecology, psychology, and policy. We illustrate the potential of this approach using highly pathogenic avian influenza (HPAI) as a case study and discuss key considerations for implementing SOS thinking in the context of global epidemic intelligence systems.
{"title":"Leveraging Systems-of-Systems Analysis to Strengthen Epidemic Intelligence for Preparedness and Response.","authors":"John M Drake, Justin Bahl, Michael A Cacciatore, Amin Ghadami, Ellie Graeden, Barbara A Han, Glen Nowak, Éric Marty, Hailey Robertson, Pejman Rohani, Sukanta Sarkar, Guppy L Stott, Amy K Winter, Bogdan I Epureanu","doi":"10.1177/23265094251396048","DOIUrl":"https://doi.org/10.1177/23265094251396048","url":null,"abstract":"<p><p>The COVID-19 pandemic exposed significant gaps in the coordination and integration of efforts required to effectively manage large-scale infectious disease outbreaks. A successful response to such crises demands the swift and ongoing synthesis of information and activities across multiple sectors, including government, healthcare, and private industry. However, these systems are often managed in isolation, leading to misaligned policies, fragmented communications, and inefficiencies that hinder pandemic response efforts. To address these challenges, we propose adopting a systems-of-systems (SOS) paradigm to enhance epidemic intelligence and improve preparedness and response during infectious disease emergencies. The SOS approach, widely used in engineering, offers a framework for integrating diverse fields such as virology, ecology, psychology, and policy. We illustrate the potential of this approach using highly pathogenic avian influenza (HPAI) as a case study and discuss key considerations for implementing SOS thinking in the context of global epidemic intelligence systems.</p>","PeriodicalId":12955,"journal":{"name":"Health Security","volume":"23 6","pages":"400-410"},"PeriodicalIF":1.6,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145722383","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-11-01Epub Date: 2025-12-04DOI: 10.1177/23265094251398546
Mariel Flores Lima, Jacqueline Cotton, Robert Faggian
In 2022, an unexpected Japanese encephalitis virus (JEV) outbreak affected Australia, causing human and pig infections. Climate conditions were previously found to be risk factors of JEV outbreaks. Hence, understanding their future risk due to climate change can help inform public health authorities of the potential JEV risk, particularly in nonendemic areas such as Victoria, Australia. Following up on a previous investigation, this study aimed to identify regions in Victoria, Australia, that might present high-risk areas of JEV in future climatic scenarios. An analytical hierarchy process with an expert panel was the methodology implemented to analyze the risk of JEV under 2 emission scenarios: SSP1-2.6 (low emission) and SSP5-8.5 (very high emission) from 2021 to 2100. Victoria showed more high-risk areas of JEV than the historical risk during the summer months under both emission scenarios and for all periods. Gippsland, Hume, and the Melbourne Metropolitan areas were the most vulnerable regions to JEV risk, with more high-risk areas also in the autumn and spring months under the SSP5-8.5 emission scenario. Climate change could exacerbate the presence of high-risk areas of JEV in Victoria, Australia, in the immediate and distant future. These results underline the urgency of preparing for outbreaks and epidemic events, particularly in regions of Victoria not currently categorized as high-risk for flavivirus outbreaks.
{"title":"Climate Change and Epidemic Preparedness: High-Risk Regions of Japanese Encephalitis Virus in Victoria, Australia, From 2021 to 2100.","authors":"Mariel Flores Lima, Jacqueline Cotton, Robert Faggian","doi":"10.1177/23265094251398546","DOIUrl":"10.1177/23265094251398546","url":null,"abstract":"<p><p>In 2022, an unexpected Japanese encephalitis virus (JEV) outbreak affected Australia, causing human and pig infections. Climate conditions were previously found to be risk factors of JEV outbreaks. Hence, understanding their future risk due to climate change can help inform public health authorities of the potential JEV risk, particularly in nonendemic areas such as Victoria, Australia. Following up on a previous investigation, this study aimed to identify regions in Victoria, Australia, that might present high-risk areas of JEV in future climatic scenarios. An analytical hierarchy process with an expert panel was the methodology implemented to analyze the risk of JEV under 2 emission scenarios: SSP1-2.6 (low emission) and SSP5-8.5 (very high emission) from 2021 to 2100. Victoria showed more high-risk areas of JEV than the historical risk during the summer months under both emission scenarios and for all periods. Gippsland, Hume, and the Melbourne Metropolitan areas were the most vulnerable regions to JEV risk, with more high-risk areas also in the autumn and spring months under the SSP5-8.5 emission scenario. Climate change could exacerbate the presence of high-risk areas of JEV in Victoria, Australia, in the immediate and distant future. These results underline the urgency of preparing for outbreaks and epidemic events, particularly in regions of Victoria not currently categorized as high-risk for flavivirus outbreaks.</p>","PeriodicalId":12955,"journal":{"name":"Health Security","volume":" ","pages":"377-388"},"PeriodicalIF":1.6,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145700773","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-11-01DOI: 10.1177/23265094251398871
Robert A Stoll, Steve S Sin, Ivan Stanish, Damon C Duquaine, Kelly J Chapman, Jane E Valentine, Alexandra M Williams, Sean T Doody, Markus K Binder
Current public health surveillance practices exhibit delays in outbreak onset detection due to time lags associated with symptom manifestation, diagnosis, and case reporting and aggregation. To accelerate disease outbreak detection, a 2-tier Human Sentinel Network (HSN) concept was proposed, consisting of wearable physiological sensors capable of detecting presymptomatic illnesses (Tier 1) that prompt individuals to enter a diagnostic testing stage (Tier 2). In the envisioned HSN concept, both wearable alerts and test results are reported automatically and immediately to a secure online platform via a dedicated application. Given the capabilities of smart wearable devices and over-the-counter test kits in the consumer market, along with advances in data analytics and computing power, the HSN represents an information stream that could complement existing surveillance tools. To assess the adoptability of the HSN, a national survey was conducted among urban and suburban centers (6,616 total adult respondents) to quantify several factors tied to recruiting and motivating HSN participation. This paper provides statistical HSN characteristics regarding demographics (age, race, education, income); smart device ownership (57% of respondents); current smart device usage patterns (47.5% of respondents with smart devices report wearing their devices at least 12 hours every day); expected participation and willingness to share data (41.2% or higher depending upon the organization managing the HSN program); compliance (88.5% of HSN participants likely to undergo testing); and methods by which survey respondents might be incentivized to participate. This survey supports a joint probability of HSN design factors that exceeds the minimum modeled coverage requirements of 0.05 (5% population coverage) to achieve a multiday detection advantage relative to traditional public health surveillance.
{"title":"Survey to Assess the Feasibility of Implementing a Human Sentinel Disease Surveillance Network Using Privately Owned Wearable Devices.","authors":"Robert A Stoll, Steve S Sin, Ivan Stanish, Damon C Duquaine, Kelly J Chapman, Jane E Valentine, Alexandra M Williams, Sean T Doody, Markus K Binder","doi":"10.1177/23265094251398871","DOIUrl":"https://doi.org/10.1177/23265094251398871","url":null,"abstract":"<p><p>Current public health surveillance practices exhibit delays in outbreak onset detection due to time lags associated with symptom manifestation, diagnosis, and case reporting and aggregation. To accelerate disease outbreak detection, a 2-tier Human Sentinel Network (HSN) concept was proposed, consisting of wearable physiological sensors capable of detecting presymptomatic illnesses (Tier 1) that prompt individuals to enter a diagnostic testing stage (Tier 2). In the envisioned HSN concept, both wearable alerts and test results are reported automatically and immediately to a secure online platform via a dedicated application. Given the capabilities of smart wearable devices and over-the-counter test kits in the consumer market, along with advances in data analytics and computing power, the HSN represents an information stream that could complement existing surveillance tools. To assess the adoptability of the HSN, a national survey was conducted among urban and suburban centers (6,616 total adult respondents) to quantify several factors tied to recruiting and motivating HSN participation. This paper provides statistical HSN characteristics regarding demographics (age, race, education, income); smart device ownership (57% of respondents); current smart device usage patterns (47.5% of respondents with smart devices report wearing their devices at least 12 hours every day); expected participation and willingness to share data (41.2% or higher depending upon the organization managing the HSN program); compliance (88.5% of HSN participants likely to undergo testing); and methods by which survey respondents might be incentivized to participate. This survey supports a joint probability of HSN design factors that exceeds the minimum modeled coverage requirements of 0.05 (5% population coverage) to achieve a multiday detection advantage relative to traditional public health surveillance.</p>","PeriodicalId":12955,"journal":{"name":"Health Security","volume":"23 6","pages":"411-420"},"PeriodicalIF":1.6,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145722352","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-11-01DOI: 10.1177/23265094251398495
Tura Galgalo, Daniel Wako, Jonas Z Hines, Elizabeth Nzioka, Muna Aden, Jedidah Kiprop, Stephen Mwatha, Joseph Ogutu, Daniel Macharia, Jack Nyamongo, Kevin Omondi, Kaitlin Sandhaus, Eric Marble, Ahmed Abade, M Kamene Kimenye, Hilary Limo, Amy Herman-Roloff
The World Health Organization (WHO) assessment of the implementation status of national public health emergency operation center (PHEOCs) showed that African countries have made considerable efforts in setting up PHEOCs at national level. In 2017, Kenya established a national PHEOC to fulfill WHO Joint External Evaluation recommendations and as part of Ebola preparedness activities. In 2020, the COVID-19 pandemic provided an opportunity to establish subnational PHEOCs, as recommended by the national COVID-19 task force. We documented experiences in establishing and operationalizing subnational PHEOCs using contemporaneous start-up notes, PHEOC monthly reports, quarterly support supervision reports, outbreak reports, and baseline and follow-up standardized assessments adapted from WHO. From October 2020 through September 2021, PHEOCs were established in 17 of the 47 counties; priority was based on the burden of COVID-19 and other infectious diseases, population size, and proximity to an international border, among other factors. Existing physical structures were repurposed and supplied with communications equipment and furniture to host the PHEOCs. County government public health workers were deployed to PHEOCs to coordinate responses through an incident management system. Technical capacity was built through in-person training, virtual webinars, and onsite mentorship. National PHEOC plans and standard operating procedures were adapted to guide operations. Repurposed structures for PHEOCs and deployment of existing county health staff were seen as key sustainable best practices. Local government buy-in was critical to the establishment of subnational PHEOCs, which have been utilized to respond to 79 events during 2020-2023. The establishment of subnational PHEOCs strengthened local public health capacity to respond to COVID-19 and outbreaks of other diseases in Kenya. Lessons from Kenya may help other countries looking to establish subnational PHEOCs.
{"title":"Establishment of Subnational Public Health Emergency Operation Centers During the COVID-19 Pandemic, Kenya, 2020-2023.","authors":"Tura Galgalo, Daniel Wako, Jonas Z Hines, Elizabeth Nzioka, Muna Aden, Jedidah Kiprop, Stephen Mwatha, Joseph Ogutu, Daniel Macharia, Jack Nyamongo, Kevin Omondi, Kaitlin Sandhaus, Eric Marble, Ahmed Abade, M Kamene Kimenye, Hilary Limo, Amy Herman-Roloff","doi":"10.1177/23265094251398495","DOIUrl":"https://doi.org/10.1177/23265094251398495","url":null,"abstract":"<p><p>The World Health Organization (WHO) assessment of the implementation status of national public health emergency operation center (PHEOCs) showed that African countries have made considerable efforts in setting up PHEOCs at national level. In 2017, Kenya established a national PHEOC to fulfill WHO Joint External Evaluation recommendations and as part of Ebola preparedness activities. In 2020, the COVID-19 pandemic provided an opportunity to establish subnational PHEOCs, as recommended by the national COVID-19 task force. We documented experiences in establishing and operationalizing subnational PHEOCs using contemporaneous start-up notes, PHEOC monthly reports, quarterly support supervision reports, outbreak reports, and baseline and follow-up standardized assessments adapted from WHO. From October 2020 through September 2021, PHEOCs were established in 17 of the 47 counties; priority was based on the burden of COVID-19 and other infectious diseases, population size, and proximity to an international border, among other factors. Existing physical structures were repurposed and supplied with communications equipment and furniture to host the PHEOCs. County government public health workers were deployed to PHEOCs to coordinate responses through an incident management system. Technical capacity was built through in-person training, virtual webinars, and onsite mentorship. National PHEOC plans and standard operating procedures were adapted to guide operations. Repurposed structures for PHEOCs and deployment of existing county health staff were seen as key sustainable best practices. Local government buy-in was critical to the establishment of subnational PHEOCs, which have been utilized to respond to 79 events during 2020-2023. The establishment of subnational PHEOCs strengthened local public health capacity to respond to COVID-19 and outbreaks of other diseases in Kenya. Lessons from Kenya may help other countries looking to establish subnational PHEOCs.</p>","PeriodicalId":12955,"journal":{"name":"Health Security","volume":"23 6","pages":"389-399"},"PeriodicalIF":1.6,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145722231","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-11-01Epub Date: 2025-12-04DOI: 10.1177/23265094251394716
Amanda Kobokovich Mui, Gigi Kwik Gronvall, Oliver Shane R Dumaoal, Viswanadham Duppatla, Benard W Kulohoma, Damaris Matoke-Muhia, Margaret W Muturi, Shambhavi Naik, George Ogello Obiero, Dorington O Ogoyi, Julie E Fischer
Gene synthesis technologies are broadly useful and increasingly ubiquitous tools for life sciences research and development of medical countermeasures. The growth of the global commercial nucleic acid synthesis market has raised concerns that these technologies might undermine measures intended to reduce biological risks, including by preventing the theft, diversion, or misuse of high-consequence pathogens. Although the members of the International Gene Synthesis Consortium have voluntarily adopted sequence and customer screening for commercial gene synthesis orders, national frameworks and institutional capacities to assess and mitigate the potential risks of misuse of gene synthesis vary widely. In this case study, we describe the use of collaborative development of simulation exercises as an approach to raise awareness among key stakeholders of potential biosecurity risks associated with use of gene synthesis, while identifying context-specific, multilayered approaches to biosecurity that can be implemented at the national and institutional level. Experts from India, Indonesia, Kenya, and the Philippines worked in mentored, virtual breakout sessions to develop simulation exercises based on first-hand knowledge of local context to inform appropriate, sustainable approaches to measures to enhance oversight of nucleic acid synthesis procurement at the institutional level or to promote adoption of national frameworks. This project reinforced the proof-of-principle that collaborative exercises can be used to address a broad variety of research governance gaps to enhance national and institutional biosecurity.
{"title":"Increasing Gene Synthesis Security Risk Awareness Through Global Engagement and Collaborative Exercise Development.","authors":"Amanda Kobokovich Mui, Gigi Kwik Gronvall, Oliver Shane R Dumaoal, Viswanadham Duppatla, Benard W Kulohoma, Damaris Matoke-Muhia, Margaret W Muturi, Shambhavi Naik, George Ogello Obiero, Dorington O Ogoyi, Julie E Fischer","doi":"10.1177/23265094251394716","DOIUrl":"10.1177/23265094251394716","url":null,"abstract":"<p><p>Gene synthesis technologies are broadly useful and increasingly ubiquitous tools for life sciences research and development of medical countermeasures. The growth of the global commercial nucleic acid synthesis market has raised concerns that these technologies might undermine measures intended to reduce biological risks, including by preventing the theft, diversion, or misuse of high-consequence pathogens. Although the members of the International Gene Synthesis Consortium have voluntarily adopted sequence and customer screening for commercial gene synthesis orders, national frameworks and institutional capacities to assess and mitigate the potential risks of misuse of gene synthesis vary widely. In this case study, we describe the use of collaborative development of simulation exercises as an approach to raise awareness among key stakeholders of potential biosecurity risks associated with use of gene synthesis, while identifying context-specific, multilayered approaches to biosecurity that can be implemented at the national and institutional level. Experts from India, Indonesia, Kenya, and the Philippines worked in mentored, virtual breakout sessions to develop simulation exercises based on first-hand knowledge of local context to inform appropriate, sustainable approaches to measures to enhance oversight of nucleic acid synthesis procurement at the institutional level or to promote adoption of national frameworks. This project reinforced the proof-of-principle that collaborative exercises can be used to address a broad variety of research governance gaps to enhance national and institutional biosecurity.</p>","PeriodicalId":12955,"journal":{"name":"Health Security","volume":" ","pages":"449-455"},"PeriodicalIF":1.6,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145700799","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-11-01DOI: 10.1177/23265094251399218
Gillian K SteelFisher, Mary G Findling, Hannah L Caporello, Alyssa Boyea, Laura Espino, Jazmyne Sutton
Vaccine innovations offer key tools to protect health, yet public views about vaccine development in the wake of COVID-19 are not well understood. We conducted a nationally representative survey of 1,632 US adults to examine public perceptions of vaccine development and false vaccine information that may shape views after the pandemic. The vast majority (81%) of adults thought vaccine development is "mostly a good thing," largely because vaccines protect the vulnerable and protect against severe illness (81% and 78%, respectively, among those who thought it was mostly a good thing). Most (78%) adults thought the spread of false vaccine information is a major problem, though few (26%) believed it is spread predominantly by people with bad intentions. Two-thirds (67%) said they had personally heard false information, but among those who gave examples, 31% provided statements that were about vaccines being beneficial, implying they believe vaccines are actually harmful. Findings suggest that public health leaders can build on largely positive public views of vaccine development, but should use caution when communicating about new vaccines and false information. It will be essential for leaders to acknowledge risks of new vaccines and avoid messages that seemingly denigrate people who might share false information.
{"title":"US Views on New Vaccine Development and False Information After COVID-19.","authors":"Gillian K SteelFisher, Mary G Findling, Hannah L Caporello, Alyssa Boyea, Laura Espino, Jazmyne Sutton","doi":"10.1177/23265094251399218","DOIUrl":"https://doi.org/10.1177/23265094251399218","url":null,"abstract":"<p><p>Vaccine innovations offer key tools to protect health, yet public views about vaccine development in the wake of COVID-19 are not well understood. We conducted a nationally representative survey of 1,632 US adults to examine public perceptions of vaccine development and false vaccine information that may shape views after the pandemic. The vast majority (81%) of adults thought vaccine development is \"mostly a good thing,\" largely because vaccines protect the vulnerable and protect against severe illness (81% and 78%, respectively, among those who thought it was mostly a good thing). Most (78%) adults thought the spread of false vaccine information is a major problem, though few (26%) believed it is spread predominantly by people with bad intentions. Two-thirds (67%) said they had personally heard false information, but among those who gave examples, 31% provided statements that were about vaccines being beneficial, implying they believe vaccines are actually harmful. Findings suggest that public health leaders can build on largely positive public views of vaccine development, but should use caution when communicating about new vaccines and false information. It will be essential for leaders to acknowledge risks of new vaccines and avoid messages that seemingly denigrate people who might share false information.</p>","PeriodicalId":12955,"journal":{"name":"Health Security","volume":"23 6","pages":"439-448"},"PeriodicalIF":1.6,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145722323","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
This review is focused on chemical, biological, radiological and nuclear (CBRN) medical countermeasures (MCMs) regulations in the United States between 2014 and 2024. Primary agencies involved in this process include the Food and Drug Administration (FDA), National Institutes of Health, Department of Homeland Security, and Centers for Disease Control and Prevention. Upon emergency declaration by the Secretary of Health and Human Services Emergency Use Authorization (EUA) goes into effect. Current regulation encompasses section 564 of Federal Food, Drug, and Cosmetic Act of 1938) governing EUA and authorizes the FDA to permit the use of unapproved medical products or unapproved uses of approved medical products to diagnose, prevent, or treat serious or life-threatening conditions caused by CBRN threat agents when no adequate, approved, and available alternatives exist. The regulation also includes Animal Rule, which allows pharmaceuticals or biologics licensing based on animal studies when conducting human efficacy studies is unethical. While expedited pathways exist for CBRN EUA, balancing speed and safety considerations is crucial. Priority Review Vouchers can be issued by the FDA to manufacturers for developing medical products during public health emergencies. While these policies and practices have worked well enough, there is room for improvement in the current regulatory framework regarding ongoing innovations, anticipated changes in regulatory policies, and global collaboration efforts. In this article, we discuss various regulatory challenges, including ethical and safety issues to be considered during the approval of MCMs for CBRN threats. Overcoming these challenges necessitates safety and efficacy demonstration of MCMs, maintaining public trust, and striking a balance between speed and safety considerations.
{"title":"Regulatory Approval of CBRN Medical Countermeasures: Current Scenario and Way Ahead.","authors":"Manan Grover, Mansi Sharma, Vikesh Kumar Shukla, Sudeep Ranjan Nayak, Navneet Sharma","doi":"10.1177/23265094251396057","DOIUrl":"10.1177/23265094251396057","url":null,"abstract":"<p><p>This review is focused on chemical, biological, radiological and nuclear (CBRN) medical countermeasures (MCMs) regulations in the United States between 2014 and 2024. Primary agencies involved in this process include the Food and Drug Administration (FDA), National Institutes of Health, Department of Homeland Security, and Centers for Disease Control and Prevention. Upon emergency declaration by the Secretary of Health and Human Services Emergency Use Authorization (EUA) goes into effect. Current regulation encompasses section 564 of Federal Food, Drug, and Cosmetic Act of 1938) governing EUA and authorizes the FDA to permit the use of unapproved medical products or unapproved uses of approved medical products to diagnose, prevent, or treat serious or life-threatening conditions caused by CBRN threat agents when no adequate, approved, and available alternatives exist. The regulation also includes Animal Rule, which allows pharmaceuticals or biologics licensing based on animal studies when conducting human efficacy studies is unethical. While expedited pathways exist for CBRN EUA, balancing speed and safety considerations is crucial. Priority Review Vouchers can be issued by the FDA to manufacturers for developing medical products during public health emergencies. While these policies and practices have worked well enough, there is room for improvement in the current regulatory framework regarding ongoing innovations, anticipated changes in regulatory policies, and global collaboration efforts. In this article, we discuss various regulatory challenges, including ethical and safety issues to be considered during the approval of MCMs for CBRN threats. Overcoming these challenges necessitates safety and efficacy demonstration of MCMs, maintaining public trust, and striking a balance between speed and safety considerations.</p>","PeriodicalId":12955,"journal":{"name":"Health Security","volume":"23 6","pages":"421-438"},"PeriodicalIF":1.6,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145722295","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-11-01DOI: 10.1177/23265094251398057
Karla C Bagley, Jennifer J Fowler, Alida M Gertz, Adria Mathis, Argelia Figueroa, David Sugerman, Francisco Alvarado-Ramy, Kayla M Lavilla, Clive M Brown, Sundari Mase, Shannon L Gearhart
Measles is highly transmissible and can lead to severe complications and mortality risk. Cases of measles are reportable to the US Centers for Disease Control and Prevention (CDC). This study describes characteristics of travelers who flew while infectious with measles and their contacts. We analyzed data from domestic and US inbound international flights reported between January 1, 2018, and December 31, 2019. To identify contacts potentially exposed to measles during air travel we used the CDC-defined measles contact zone and crossmatched with the CDC measles database. We conducted a descriptive analysis of travelers with measles and their aircraft contacts and determined average time from flight exposure to contact interview. During the analysis period, CDC received reports of 83 air travelers infectious with measles resulting in 5,186 potential aircraft exposures. Health departments provided data to CDC for 39% (n=2,037) of the exposures/contacts. On average, 9.8 days elapsed between flight exposure and initial interview attempt. Of the 2,037 contacts interviewed, 82% (n=1,680) reported a history of vaccination or prior disease. Seven secondary cases were identified. Five were exposed on US inbound international flights, 5 had no history of vaccination, and 4 were seated outside the contact zone. Most contacts who developed measles were unvaccinated and shared a US inbound international flight with an infected traveler. Over half of secondary cases were outside the contact zone. The average first contact interview attempt occurred beyond the 3-day window for effective prophylaxis. Continued emphasis on measles vaccination, evaluation of the contact zone definition, and timely contact investigation of exposed travelers may prevent secondary cases and outbreaks in the United States.
{"title":"Descriptive Analysis of Measles Transmission Among Travelers During Domestic and Inbound US International Air Travel, 2018-2019.","authors":"Karla C Bagley, Jennifer J Fowler, Alida M Gertz, Adria Mathis, Argelia Figueroa, David Sugerman, Francisco Alvarado-Ramy, Kayla M Lavilla, Clive M Brown, Sundari Mase, Shannon L Gearhart","doi":"10.1177/23265094251398057","DOIUrl":"10.1177/23265094251398057","url":null,"abstract":"<p><p>Measles is highly transmissible and can lead to severe complications and mortality risk. Cases of measles are reportable to the US Centers for Disease Control and Prevention (CDC). This study describes characteristics of travelers who flew while infectious with measles and their contacts. We analyzed data from domestic and US inbound international flights reported between January 1, 2018, and December 31, 2019. To identify contacts potentially exposed to measles during air travel we used the CDC-defined measles contact zone and crossmatched with the CDC measles database. We conducted a descriptive analysis of travelers with measles and their aircraft contacts and determined average time from flight exposure to contact interview. During the analysis period, CDC received reports of 83 air travelers infectious with measles resulting in 5,186 potential aircraft exposures. Health departments provided data to CDC for 39% (n=2,037) of the exposures/contacts. On average, 9.8 days elapsed between flight exposure and initial interview attempt. Of the 2,037 contacts interviewed, 82% (n=1,680) reported a history of vaccination or prior disease. Seven secondary cases were identified. Five were exposed on US inbound international flights, 5 had no history of vaccination, and 4 were seated outside the contact zone. Most contacts who developed measles were unvaccinated and shared a US inbound international flight with an infected traveler. Over half of secondary cases were outside the contact zone. The average first contact interview attempt occurred beyond the 3-day window for effective prophylaxis. Continued emphasis on measles vaccination, evaluation of the contact zone definition, and timely contact investigation of exposed travelers may prevent secondary cases and outbreaks in the United States.</p>","PeriodicalId":12955,"journal":{"name":"Health Security","volume":"23 6","pages":"464-471"},"PeriodicalIF":1.6,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12823029/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145722192","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-09-01Epub Date: 2025-10-08DOI: 10.1177/23265094251384642
Tobias Ramiro Filippini, Andres Hunt, M Gabriela Lagorio, Gabriela Cordon, Virginia Diz, Graciela A González
This article presents results from The Plant Biomarker Challenge, an initiative funded by the Organization for the Prohibition of Chemical Weapons. The proposed platform-a plant species and measurement methodology-distinguishes between unexposed plants and those exposed to chlorpyrifos, a model organophosphorus pesticide. These compounds are active ingredients in pesticides and chemical warfare agents. Plants expressing acetylcholinesterase activity are affected by such compounds and can serve as biomarkers for accidental or criminal exposures, which is the focus of this study. An electrochemical method is proposed to assess pesticide exposure by analyzing alterations in acetylcholinesterase enzymatic activity. Initial assays in aqueous phase validate the mechanism, complemented by infrared spectrometry, before transitioning to plant samples. Chicory extracts exposed to varying chlorpyrifos concentrations are analyzed, enabling differentiation between nonexposed plants and those subjected to doses exceeding one-tenth of the manufacturer's recommended mean dose. Electrochemical impedance spectroscopy evaluates acetylcholinesterase activity indirectly via its reaction with acetylthiocholine chloride and the subsequent interaction between generated thiocholine and silver nanoparticles. This comprehensive system integrates plant species and a measurement method to detect environments exposed to organophosphates.
{"title":"Bioplatform for Detecting Organophosphorus Compound Exposure.","authors":"Tobias Ramiro Filippini, Andres Hunt, M Gabriela Lagorio, Gabriela Cordon, Virginia Diz, Graciela A González","doi":"10.1177/23265094251384642","DOIUrl":"10.1177/23265094251384642","url":null,"abstract":"<p><p>This article presents results from The Plant Biomarker Challenge, an initiative funded by the Organization for the Prohibition of Chemical Weapons. The proposed platform-a plant species and measurement methodology-distinguishes between unexposed plants and those exposed to chlorpyrifos, a model organophosphorus pesticide. These compounds are active ingredients in pesticides and chemical warfare agents. Plants expressing acetylcholinesterase activity are affected by such compounds and can serve as biomarkers for accidental or criminal exposures, which is the focus of this study. An electrochemical method is proposed to assess pesticide exposure by analyzing alterations in acetylcholinesterase enzymatic activity. Initial assays in aqueous phase validate the mechanism, complemented by infrared spectrometry, before transitioning to plant samples. Chicory extracts exposed to varying chlorpyrifos concentrations are analyzed, enabling differentiation between nonexposed plants and those subjected to doses exceeding one-tenth of the manufacturer's recommended mean dose. Electrochemical impedance spectroscopy evaluates acetylcholinesterase activity indirectly via its reaction with acetylthiocholine chloride and the subsequent interaction between generated thiocholine and silver nanoparticles. This comprehensive system integrates plant species and a measurement method to detect environments exposed to organophosphates.</p>","PeriodicalId":12955,"journal":{"name":"Health Security","volume":" ","pages":"348-357"},"PeriodicalIF":1.6,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145250880","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-09-01Epub Date: 2025-10-03DOI: 10.1177/23265094251381803
Frederico S Duque Estrada Meyer, Leandro Antunes Mariosi
Marking the 50th anniversary of the Biological Weapons Convention (BWC), this commentary examines adaptive strategies underpinning the treaty's resilience within an increasingly complex and fragmented global biosecurity ecosystem. By conceptualizing the BWC as an autopoietic subsystem-one that is self-sustaining and yet structurally coupled to its environment-we argue that the BWC's historical effectiveness in preventing large-scale biological weapons use derives from its capacity for normative memory. Its reflexive operation enables the treaty to continuously reinterpret and apply its foundational prohibition amid evolving scientific and technological landscapes. Recent advancements in synthetic biology, bioinformatics, and artificial intelligence intensify risks by blurring boundaries between biosafety and biosecurity, between peaceful and weaponized biotechnology applications, challenging the BWC's ability to differentiate clearly between permissible and prohibited activities. In response, internal structural differentiation through specialized frameworks becomes essential, notably via the proposed science and technology mechanism. This body would function explicitly as a structural coupling device, mediating uncertainty and translating the flux of scientific possibility into legally referable categories without collapsing the normative autonomy of the Convention. Concurrently, the international cooperation and assistance mechanism would enhance global preparedness and interoperability among cross-disciplinary biosecurity communities. The COVID-19 pandemic underscored the urgency for institutional adaptability, heightened preparedness, and proactive engagement across disciplines. Analyzing ongoing diplomatic negotiations within the Working Group on the Strengthening of the BWC, we highlight substantial convergences alongside residual divergences across 7 key topics: international cooperation and assistance; science and technology; compliance and verification; confidence-building measures; assistance, response and preparedness; national implementation; and organizational, institutional, and financial arrangements. Ultimately, we advocate for integration of scientific expertise and diplomatic practice, emphasizing sustained interdisciplinary collaboration and robust institutional commitment as prerequisites for ensuring the BWC's normative vitality and operational efficacy for decades to come.
{"title":"Survival by Design: The BWC's Autopoietic Response at Fifty to a Disaggregated Biosecurity Ecosystem.","authors":"Frederico S Duque Estrada Meyer, Leandro Antunes Mariosi","doi":"10.1177/23265094251381803","DOIUrl":"10.1177/23265094251381803","url":null,"abstract":"<p><p>Marking the 50th anniversary of the Biological Weapons Convention (BWC), this commentary examines adaptive strategies underpinning the treaty's resilience within an increasingly complex and fragmented global biosecurity ecosystem. By conceptualizing the BWC as an autopoietic subsystem-one that is self-sustaining and yet structurally coupled to its environment-we argue that the BWC's historical effectiveness in preventing large-scale biological weapons use derives from its capacity for normative memory. Its reflexive operation enables the treaty to continuously reinterpret and apply its foundational prohibition amid evolving scientific and technological landscapes. Recent advancements in synthetic biology, bioinformatics, and artificial intelligence intensify risks by blurring boundaries between biosafety and biosecurity, between peaceful and weaponized biotechnology applications, challenging the BWC's ability to differentiate clearly between permissible and prohibited activities. In response, internal structural differentiation through specialized frameworks becomes essential, notably via the proposed science and technology mechanism. This body would function explicitly as a structural coupling device, mediating uncertainty and translating the flux of scientific possibility into legally referable categories without collapsing the normative autonomy of the Convention. Concurrently, the international cooperation and assistance mechanism would enhance global preparedness and interoperability among cross-disciplinary biosecurity communities. The COVID-19 pandemic underscored the urgency for institutional adaptability, heightened preparedness, and proactive engagement across disciplines. Analyzing ongoing diplomatic negotiations within the Working Group on the Strengthening of the BWC, we highlight substantial convergences alongside residual divergences across 7 key topics: international cooperation and assistance; science and technology; compliance and verification; confidence-building measures; assistance, response and preparedness; national implementation; and organizational, institutional, and financial arrangements. Ultimately, we advocate for integration of scientific expertise and diplomatic practice, emphasizing sustained interdisciplinary collaboration and robust institutional commitment as prerequisites for ensuring the BWC's normative vitality and operational efficacy for decades to come.</p>","PeriodicalId":12955,"journal":{"name":"Health Security","volume":" ","pages":"292-299"},"PeriodicalIF":1.6,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145225380","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}